Kornimate/medical-research-clean huggingface dataset:
safety study of intracranial support catheter and guide catheter for stent-assisted embolization in the treatment of intracranial aneurysms

Conditions: Intracranial Aneurysm

Summary: the purpose of this study is to evaluate the safety differences between intracranial support catheter and guide catheter for stent-assisted embolization in the treatment of unruptured intracranial aneurysms in the anterior circulation.

this is a prospective, multicenter, randomized, open, controlled, superiority trial carried out in 9 research centers over china. patients are randomized 1:1 to therapy either intracranial support catheter or guide catheter. taking the guide catheter as a control, to evaluate whether the safety of intracranial support catheter for stent-assisted embolization in the treatment of unruptured intracranial aneurysms in the anterior circulation is superior than that of the control.

Eligibility criteria:
inclusion criteria: * age≥18 and≤70 years, any gender; * preoperative modified rankin scale (mrs) score 0-2; * subject has an unruptured intracranial aneurysm in the anterior circulation diagnosed by dsa/cta/mra (accept the results from other hospital)； * no intracranial hemorrhage and recent cerebral infarction (dwi indicates hyperintense lesions) are founded by preoperative mri+dwi; * subject is assessed as suitable for stent-assisted coil embolization (sace) treatment (except flow diverter stent); * subject or guardian is able to understand the purpose of study, shows sufficient compliance with the study protocol and provides a signed informed consent form. exclusion criteria: * inadequate antiplatelet therapy before surgery (more than 3 days); * subject with atrial fibrillation, patent foramen ovale, atrial septal defect, ventricular septal defect, and other diseases causing cardiogenic embolism; * inability to perform cranial mri+dwi preoperatively and within 48 hours postoperatively; * hypertension that does not respond well to medical treatment (systolic blood pressure\>185 mmhg and/or diastolic blood pressure\>110 mmhg); * preoperative active bleeding or bleeding tendency (inr\>3); * random blood glucose\ 22.2mmol/l; * heart, lung, liver and kidney failure or other serious diseases (intracranial tumor, intracranial arteriovenous malformation, severe infection, dic, previous myocardial infarction, history of severe psychosis, etc.); * subject who will not cooperate or tolerate interventional operation; * anticipated life expectancy\<1 year; * allergy, resistance or contraindication to one or more of the following: contrast agents, anesthetics, antiplatelet drugs, anticoagulants; * participated or participating in another drug or device clinical trial within 1 month prior to enrollment; * pregnant or breast-feeding woman; * other circumstances judged by researchers that are not suitable for enrollment; * catheter could not pass through due to obvious intracranial vessel stenosis or tortuosity determined from imaging; * multiple aneurysms and more than one aneurysm requiring treatment; * the aneurysm body has arterial branches.
near-infrared fluorescence with indocyanine green for identification of sentinels and parathyroids during thyroidectomy

Conditions: Thyroid Cancer; Thyroid Carcinoma, Papillary; Thyroid Metastases; Thyroid Neoplasms; Sentinel Lymph Node; Lymph Node Metastases

Summary: indocyanine green (icg) is a water-soluble organic dye that is cleared totally through the hepatobiliary system. it has a half-life of 3-4 mins, which allows repeated applications. near-infrared (nir) fluorescence imaging with indocyanine green (icg) imaging has been recently introduced, and has been suggested as a useful tool for the identification and preservation of the parathyroid glands (pgs) during total thyroidectomy (tt). icg can also be used for sentinel lymph node (sln) biopsy to predict the micrometastases in central lymph nodes (cln) in thyroid carcinoma, and central lymph node dissection can reduce local recurrence.

incidence of thyroid cancer has doubled between 1980 and 2020, and it is now the fifth most common malignant tumor among women. the majority are papillary thyroid cancer (ptc), and tt is the procedure of choice. since the micrometastasis rate of the central lymph nodes (clns) is about 30% to 90% in ptc, cln dissection can improve the prognosis and reduce tumor recurrence as well as provide accurate information for the evaluation of tumor staging. however, tt procedure has some important complications such as vocal cord paralysis (vcp) and hypocalcemia (due to accicental parathyroidectomy or damage to the parathyroid gland-pg- vasculature). use of intraoperative nerve monitoring (ionm) has reduced the rate of vcp. however, the incidence of postoperative hypocalcemia is still high (15-70%), and it is now the most common complication of tt. intraoperative identification of slns and pgs can help surgeon to overcome these problems.

Eligibility criteria:
inclusion criteria: * thyroid carcinoma patients (biopsy/cytology-proven) suitable for total thyroidectomy procedure * patients at or over 17 years exclusion criteria: * previous thyroid surgery * patients below 17 years

Keywords: near-infrared (nir) fluorescence total thyroidectomy parathyroid glands indocyanine green (icg) central lymph node dissection
evaluation of pandemic influenza a (h1n1) vaccine in chronic and or immunocompromised patients, elderly and pregnants

Conditions: Immunocompromised Patients; Safety of Pandemic Influenza A (H1N1)Vaccine; Immunogenicity of Pandemic Influenza A (H1N1)Vaccine

Summary: the objective of this study is to describe the safety and immunogenicity of a non-adjuvanted vaccine against pandemic influenza a (h1n1)in patients with chronic and or immunocompromised disease, elderly and pregnants. the primary immunological endpoint is to analyze the proportion of subjects with antibody titers of 1:40 or more on hemagglutination-inhibition assay 21 days after 1 dose of the vaccine. volunteers will be monitored for safety during 21 days after vaccination. volunteers will be recruited based on inclusion and exclusion criteria. vaccine composition is: 15 micrograms of split inactivated virus (a/california/7/2009 (h1n1) (nymc x179a). the hypothesis of the study is that the vaccine is safe and immunogenic in the volunteers recruited.


Eligibility criteria:
inclusion criteria: * volunteers able to understand and agree to participate in the study. exclusion criteria: * have egg allergy * have past history of allergy to seasonal influenza vaccine * have received another inactivated vaccine within the prior 2 weeks or live vaccine in the past four weeks to his/her participation in the study * acute infectious disease during seven days prior vaccination * confirmed prior infection by pandemic influenza a (h1n1) * have participated in another clinical trial in the last 6 months * any other condition identified by the principal investigators which is considered not safe for enrollment of the volunteer.

Keywords: immunocompromised patients safety of pandemic influenza a (h1n1)vaccine immunogenicity of pandemic influenza a (h1n1)vaccine
pain management during diagnostic office hysteroscopy in postmenopausal women: a randomized study

Conditions: Office Hysteroscopy

Summary: to assess the effectiveness of lidocaine-prilocaine spray versus placebo in minimizing the pain experienced by postmenopausal patients during diagnostic ofﬁce hysteroscopy and to assess the ease of insertion of hysteroscope as reported by the hysteroscopists

to assess the effectiveness of lidocaine-prilocaine spray versus placebo in minimizing the pain experienced by postmenopausal patients during diagnostic ofﬁce hysteroscopy and to assess the ease of insertion of hysteroscope as reported by the hysteroscopists

Eligibility criteria:
inclusion criteria: * menopausal patients with an indication for ofﬁce hysteroscopy (postmenopausal bleeding or abnormal ultrasound ﬁndings) exclusion criteria: * nulliparous patients patients with cervical pathology retroverted uterus (detected by transvaginal ultrasound) previous cervical surgery patients with severe vaginal bleeding allergy or contraindications to lidocaine-prilocaine spray
effects of fenofibrate on the safety, toleration and efficacy biomarkers of cp-742,033

Conditions: Obesity

Summary: the purpose of this study is to determine whether fenofibrate effects the toleration, safety, or efficacy biomarkers of cp-742,033, a drug being developed for the treatment of obesity.


Eligibility criteria:
inclusion criteria: * bmi of 30-40 kg/m2 exclusion criteria: * women of childbearing potential
the comparison with clinical impacts on functional capacity and symptom improvement according to the rhythm control in patients with heart failure and recent onset atrial fibrillation

Conditions: Heart Failure; Recent Onset Atrial Fibrillation

Summary: prospective randomized (rhythm control or rate control in heart failure patients with new onset atrial fibrillation) objective of study 1. to analyze long term outcome of patients with heart failure with new onset atrial fibrillation according to the rhythm control 2. to analyze remodeling of atrium and ventricle by the new onset af in heart failure patients 3. to analyze the change of lv function and functional capacity according to the rhythm in patients with hf and new onset af


Eligibility criteria:
inclusion criteria: 1. patients with heart failure and atrial fibrillation within 1year (20\~80 years old) 2. la diameter \< 5mm 3. lvef 20\~49% 4. patients possible to anticoagulation and anti arrhythmic drug 5. expected survival \>1yr exclusion criteria: 1. impossible to anticoagulation or anti arrhythmic drug 2. valvular atrial fibrillation ( mitral valve stenosis, mitral valve plasty, valve replacement) 3. lv ejection fraction \< 20% 4. structural cardiac disease 5. catheter ablation history for af, maze surgery 6. patient with severe medical disease 7. impossible to anticoagulation or anti arrhythmic drug
a pharmacokinetic comparison of three butyrate products

Conditions: Gastro-Intestinal Disorder

Summary: this study is a randomized, three-arm, interventional study of n=10 apparently healthy men. this study will quantify plasma butyrate responses to a single dose of three different butyrate products.


Eligibility criteria:
inclusion criteria: * provide voluntary signed and dated informed consent. * be in good health as determined by medical history and routine blood chemistries. * age between the ages of 25 and 45 (inclusive). * body mass index of 18.5-24.9 (inclusive). * body weight of at least 110 pounds. * normotensive (seated, resting systolic blood pressure \<140 mm hg and diastolic blood pressure \< 90 mm hg. if the first measurement is slightly elevated above these limits, the subject will be given a brief (5-minute) rest period, and two more measurements will be taken. the average of all three measurements will be used to determine eligibility. * normal seated, resting heart rate (\<90 per minute). * willing to duplicate their previous 24-hour diet, refrain from alcohol, caffeine, and exercise for 24 hours and fast for 10 hours prior to each of the treatments. * participant agrees to maintain existing dietary and physical activity patterns throughout the study period. * participant is willing and able to comply with the study protocol. exclusion criteria: * a history of unstable or new-onset cardiovascular/cardiorespiratory, liver, or renal disease. * the participant's alcohol consumption is more than two standard alcoholic drinks per day or more than 10 drinks per week or has a history of drug/alcohol abuse or dependence. * history of diabetes (any form) or any endocrine disorder. * fasting blood sugar of \> 125 mg/dl. * current smokers or smoking cessation within the past month (28 days). * history of hyperparathyroidism or an untreated thyroid disease. * history of malignancy in the previous five years except for non-melanoma skin cancer (basal cell cancer or squamous cell cancer of the skin). * any history of gastrointestinal bypass surgery, etc., or any known functional gastrointestinal disorder that may impact nutrient absorption, e.g., short bowel syndrome, atrophic gastritis, ibd, diarrheal illnesses, history of colon resection, gastroparesis, gastric resection, celiac disease, or inherited errors of metabolism (such as pku). * chronic inflammatory condition or disease (e.g., rheumatoid arthritis, crohn's disease, ulcerative colitis, lupus, hiv/aids, etc.). * history of using butyrate or tributyrin-containing dietary supplements within the past seven days. * known allergy or sensitivity to any ingredient in the test formulations as listed on the product label. * any other diseases or conditions that, in the opinion of the medical staff, could confound the primary endpoints or place the subject at increased risk of harm if they were to participate.
treatment of gastrocnemius tightness and subsequent chronic plantar fasciitis with botulinum toxin a

Conditions: Plantar Fascitis; Gastrocnemius Tightness

Summary: this prospective clinical cohort study will follow 40 patients who recieve botulinum toxin a treatment for proximal medial gastrocnemius tightness with subsequent chronic plantar fasciitis for two years. three injections of botulinum toxin (75iu) will be administered with intervals of three months. participants will be followed at baseline, 3 months, 6 months, 1 year and 2 years with patient related outcome measures (proms) and physical test (ergotest and ankle dorsiflexion).

the connection between gastrocnemius tightness and plantar fasciitis has been demonstrated in several clinical studies. patients with chronic pathology, and unsatisfactory results from physical therapy, may benefit from gastrocnemius lengthening. this is usually obtained with proximal medial gastrocnemius recession surgery (pmgr), but recent studies and recent experience from our hospital suggest that similar effect may be obtained with ultrasound guided- injections of botulinum toxin a injections in the proximal medial gastrocnemius muscle. this study will follow patients with gastrcnemius tightness (demonstrated by the silferskiolds test) and subsequent chronic (mri-verified) plantar fasciitits who has not recieved satisfactiory results from at least three months of guided physcial therapy. participants will recieve three ultrasound guided injections of 75iu of botulinum toxin a with three month intervals. they will be followed with clinical controls for two years after the first injection. the main outcome is the manchester oxford foot questionnaire (moxfq).

Eligibility criteria:
inclusion criteria: 1. age 18-75 years. 2. an isolated gastrocnemius contracture must be verified with the silfverskiölds test before inclusion. 3. diagnosis plantar fasciitis verified clinically by an orthopaedic surgeon. 4. diagnosis verified by mri. mri criteria: thickening of the plantar fascia, oedema in the calcaneus, pathological signal changes in the plantar fascia (35) 5. duration of symptoms must be at least 12 months prior to first bta injection. 6. conventional physical therapy must have been tried at least three months without a significant reduction of symptoms in the affected foot. exclusion criteria: 1. previously undergone surgery for plantar fasciitis. 2. patients with severe talocrural pathology or serious malalignment of foot and ankle 3. severely reduced peripheral circulation 4. history of alcoholism, drug abuse, psychological or other emotional problems likely to jeopardize informed consent. 5. patients with a contraindication/non-compliance for mri examination. 6. history of allergic reaction/anaphylactic reaction or other contraindication to botulinum toxin. 7. not able to read and/or speak a scandinavian language or english adequately.

Keywords: proximal medial gastrocnemius recession gastrocnemius tightness botox botulinum toxin a
emergency department longitudinal integrated care

Conditions: Opioid-use Disorder; Emergency Department

Summary: the overarching goal of this investigation is to develop and determine the feasibility of a multi-component intervention adapted from a collaborative care framework initiated in the ed for patients at risk for opioid use disorder. this study will provide important feasibility information for future studies of ed-linc. the collaborative care intervention (ed-linc) will be supported by a novel emergency departement (ed) health information exchange platform.

the overarching goal of this investigation is to develop and determine the feasibility of a multi-component intervention adapted from a collaborative care framework initiated in the ed for patients at risk for opioid use disorder. according to the 2015 national survey on drug use and health, an estimated 3.8 million individuals over 12 years of age were currently misusing opioid pain relievers. an additional 329,000 people use heroin. the emergency department (ed) is currently at the forefront of this public health emergency and often a place where patients come for treatment of overdose and for treatment of medical problems related to illicit opioid use. overall, the goal is to establish the feasibility of a multi-component intervention called 'emergency department longitudinal integrated care (ed-linc)' which is guided by principles of collaborative care and is comprised of components that are evidence-based. ed-linc is initiated from the ed and continues longitudinally for patients at-risk for opioid use disorder.

Eligibility criteria:
inclusion criteria: * aged 18-65 * patients with at least one risk factor for opioid use disorder via the emr pre-screen * patients with score of ≥ 4 on the nida modified assist for illicit opioids (e.g. heroin) or a score of ≥ 4 on the nida modified assist for prescription opioids * currently have a phone * able to provide a phone number and one additional piece of contact information exclusion criteria: * they are incarcerated or under arrest * non-english speaking * live beyond a 50 mile radius of hmc * require active resuscitation in the ed or other clinical area at the time of ra approach * are receiving palliative care services or hospice care for a chronic illness such as metastatic cancer * are in the ed or hospital for a primary psychiatric emergency such as suicidal ideation or attempt * receiving chronic opioid therapy (cot) defined as prescription opioids for most days out of the last 90 days for a chronic pain condition * in the ed for sexual assault

Keywords: opioid use emergency department collaborative care
clinical evaluation of the carto™ xp ep navigation system v9 and biosense webster soundstar 3d diagnostic ultrasound. a feasibility study

Conditions: Cardiac Arrhythmias

Summary: feasibility study to evaluate carto™ xp ep navigation system v9 and soundstar 3d diagnostic ultrasound catheter.

to construct geometric representation of the heart chambers using intracardiac ultrasound.the carto™ xp electrophysiology (ep) navigation system v9 is intended to acquire real-time catheter based cardiac electrophysiogical maps.

Eligibility criteria:
inclusion criteria: * subjects undergoing any eps study and or ablation will be eligible for this study. age 18 years or older signed patient informed consent form exclusion criteria: * patients with inadequate vascular access patients with any of the following criteria will be excluded: * women who are pregnant * age \<18 years * any contraindication to the clinical procedure * sepsis * major coagulation abnormalities * presence of any intracardiac thrombus * unstable angina * uncontrolled heart failure * deep vein thrombosis * significant peripheral vascular disease
a trial investigating the accuracy and precision of the bgstar® and ibgstar® blood glucose meter in subjects with type 1 diabetes

Conditions: Diabetes Mellitus

Summary: due to continuing technological progress and better understanding of the needs for glucose monitoring, the performance requirements of blood glucose meters, primarily regarding their accuracy, are constantly debated and keep evolving as a consequence. recently a discussion was initiated by the food and drug administration (fda) to improve the accuracy of bg meters in the point-of-care testing setting by asking for fulfilment of higher requirements.


Eligibility criteria:
inclusion criteria: 1. signed and dated informed consent obtained before any trial-related activities. trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial. 2. male or female subjects aged 18-74 years (both inclusive). 3. type 1 diabetes mellitus (as diagnosed clinically) ≥ 12 months. 4. body mass index 18.0-28.0 kg/m2 (both inclusive). 5. hba1c ≤ 9.0 % by local laboratory analysis. exclusion criteria: 1. known or suspected hypersensitivity to lancet fingerpricks / needle injections. 2. previous participation in this trial. participation is defined as having performed at least one bg meter measurement as part of the study. 3. receipt of any investigational medicinal product within 30 days before randomisation in this trial. 4. formation of callus on the fingertips or any other skin condition that may hamper fingerprick blood sampling and/or insufficient capillary blood volume sampling (\< 50 μl) during test fingerprick(s). 5. haemoglobin \ 3x the upper limit of normal (uln), and alanine aminotransferase (alt), aspartate aminotransferase (ast), alkaline phosphatase (alp) and gamma-glutamyl transferase (γ-gt) \> 2 x uln. 6. suffer from or history of a life threatening disease (i.e. cancer except basal cell skin cancer or squamous cell skin cancer), or any clinically significant respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological (with the exception of diabetes mellitus and euthyroid struma), haematological, dermatological, venereal, -
neuromuscular electrical stimulation and mobility in multiple sclerosis

Conditions: Multiple Sclerosis

Summary: the purpose of this study is to investigate the capacity of a 6-week treatment with neuromuscular electrical stimulation to improve walking in individuals whose mobility has been compromised by multiple sclerosis.

participants will be randomly assigned to one of two study arms. those in one arm will receive a treatment with narrow stimulus pulses (0.4 ms) and those in the other arm will receive wide stimulus pulses (1 ms). the electrical stimulation will be delivered with a vectra genisys system.

Eligibility criteria:
inclusion criteria: * able to read, understand, and speak english to ensure safe participation in the project * difficulties with walking * on stable doses of ampyra, provigil, or other symptomatic-treating medications * no systemic steroids within the last 30 days * not currently exercising more than 2x/wk * able to arrange own transportation to and from the laboratories * provide informed consent, including willingness to be randomly assigned to one of the two groups exclusion criteria: * documented ms-related relapse in the last 3 months * medical diagnosis or condition that is considered to be an absolute or relative contraindication to participating in exercise training, such as major renal, pulmonary, hepatic, cardiac, gastrointestinal, hiv, cancer (other than treated basal cell cancer), other neurological disorders, or pregnancy * poorly controlled diabetes mellitus or hypertension * history of seizure disorders * alcohol dependence or abuse (≥2 drinks/day), or present history (last 6 months) of drug abuse * inability to attend exercise sessions 3 days per week for 6 weeks

Keywords: walking mobility neuromuscular electrical stimulation multiple sclerosis